Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
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|ClinicalTrials.gov Identifier: NCT02175680|
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 15, 2016
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.
|Condition or disease||Intervention/treatment||Phase|
|HIV Human Immunodeficiency Virus||Drug: PRO 140 350mg weekly SQ injection.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Drug: PRO 140 350mg weekly SQ injection.
- Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ]
- Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ]
- Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: 14 Weeks ]
- Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ]
- Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175680
|United States, California|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Jacob Lalezari, MD|